Abiomed Breethe OXY-1 System 1000140Recalls & reported problems
Breethe, Inc. · Abiomed Breethe OXY-1 PLU Disposable · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00860001797916), received between Jan 7, 2026 and Jan 7, 2026 — classified as 1 death.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Ischemia1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathJan 7, 2026Adverse Event Without Identified Device or Use Problem
THE COMPLAINANT REPORTED THAT DOPPLER SIGNALS WERE NOT DETECTED IN THE PATIENT¿S LEFT FOOT. THE PATIENT SUBSEQUENTLY EXPIRED.
Patient problems: Ischemia
MAUDE report 23999998 ↗
Other Oxygenator, Cardiopulmonary Bypass devices
- HLS Set BEQ-HLS 7050 USAMaquet Cardiopulmonary AG · Oxygenator, Cardiopulmonary Bypass3 recalls13 deaths90 reports
- Affinity Fusion® BB811Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS2 recalls90 reports
- HLS Set BEQ-HLS 5050 USAMaquet Cardiopulmonary AG · Oxygenator, Cardiopulmonary Bypass3 recalls4 reports
- NA HLS Set Advanced 5.0, Small Adult, BIOLINE CoatingMaquet Cardiopulmonary AG · OXYGENATOR, CARDIOPULMONARY BYPASS3 recalls0 reports
- A.M.G. PMP Sterile A.M.G. Module PMP NO T.P. SterileEurosets Srl · Oxygenator, Cardiopulmonary Bypass2 deaths106 reports
- CAPIOX®FX CX*FX25RWTerumo Corporation · Oxygenator, Cardiopulmonary Bypass2 deaths102 reports
- CAPIOX®RX CX*RX25RWTerumo Corporation · Oxygenator, Cardiopulmonary Bypass1 death102 reports
- QUADROX-i HMO 50000-USA #SQUADROX-i Small Adult, no FilterMaquet Cardiopulmonary AG · OXYGENATOR, CARDIOPULMONARY BYPASS2 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page